(29 days)
Not Found
No
The summary describes a passive receive coil for MRI and does not mention any software or processing capabilities that would involve AI/ML.
No.
The device is used for imaging and diagnosis, not for treating a disease or condition. It produces images and spectra that provide information useful for making diagnoses, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as producing images and spectra that, when interpreted by a trained physician, can provide information "useful in making diagnoses," which is the definition of a diagnostic device.
No
The device description explicitly states it is a "set consisting of two coils" and mentions physical components like a "coupling loop is connected with a cable." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The description clearly states that this device is a receive type surface coil used in MR systems to produce images and spectra of internal structures of the brain and body surface. It works by detecting magnetic resonance signals from protons within the body.
- No Specimen Handling: There is no mention of collecting, preparing, or examining specimens taken from the body. The device interacts directly with the patient's body to acquire data.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cordless coil is a receive type surface coil.
When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a when about in alle interese to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), and spin-spin echo time (T2) of the corresponding nucleus.
When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.
Product codes
LNH, MOS
Device Description
The Cordless Coil. It is a set consisting of two coils. The coupling loop is connected with a cable and one receive coil is inductively coupled to the other.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
brain and body surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Section 1: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in This Sunmilling of 51 (tr). Sales) and 21 CFR § 807.92.
| I. General Information
Device Name | Trade Name: Cordless coil
Classification Name: Magnetic Resonance Diagnostic Device
CFR Section: CFR § 892.1000
Classification: Class II
Product Code: LNH |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Rapid Biomedical GmbH
Technologiepark Wuerzburg-Rimpar
Kettelerstrasse 3-11
D-97222 Rimpar, Bayern
Germany |
| Initial Importer/Distributor | Siemens Medical Solutions, Inc.
51 Valley Stream Parkway
Malvern, PA 19355 |
| Registration Number | 2240869 |
| Contact Person | Ms. Ana Ladino
Technical Specialist, Regulatory Affairs
Siemens Medical Solutions
51 Valley Stream Parkway E-50
Malvern, PA 19355
Phone: (610) 448-1785
Fax: (610) 448-1787
Email: ana.ladino@siemens.com |
| Performance Standards | None established under Section 514 the Food, Drug, and Cosmetic Act. |
1
II. Safety and Effectiveness Supporting Substantial Equivalence
Intended Use
The Cordless coil is a receive type surface coil.
When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a when about in alle interese to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), and spin-spin echo time (T2) of the corresponding nucleus.
When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.
Device Description
Device Deserplish
The Cordless Coil. It is a set consisting of two coils. The coupling loop is connected with a cable and one receive coil is inductively coupled to the other.
Substantial Equivalence
Rabid and Siemens believe that, within the meaning of the Safe Medical Devices Act of 1990, the cordless coil for MAGNETOM Concerto and MAGNETOM C! is substantially equivalent to :
| Coil Name | Premarket Notification | Clearance Date |
|---|---|---|
| Coils used with Siemens Medical Solutions | ||
| MAGNETOM Concerto | K003192 | 12/21/2000 |
| Coils used with Siemens Medical Solutions | ||
| MAGNETOM C! | K043030 | 12/09/2004 |
The Cordless Coil for MAGNETOM Concerto and C! described in this Premarket Notification has the same intended use and similar technical characteristics as the devices listed above. In summary, Rapid Biomedical and Siemens are of the opinion that the Cordless coil does not introduce any new safety risks and is substantially equivalent to, and performs as well as, the predicate devices.
General Safety and Effectiveness Concerns
The cordless coil for MAGNETOM Concerto and MAGNETOM C! will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standard for safety issues with Magnetic Resonance Imaging Devices, IEC 60601-2-33: 2002. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Concerto and C! systems.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ana Ladino Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 MALVERN PA 19355
MAR 2 5 2005
Re: K050476 Trade/Device Name: Cordless Coil for MAGNETOM Concerto and MAGNETOM C! MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: MOS Dated: February 18, 2005 Received: February 24, 2005
Dear Ms. Ladino:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KUS 04 76 510(k) Number (if known) __
Cordless Coil for MAGNETOM Concerto and MAGNETOM Device Name: C! MR Systems.
Indications for Use:
The Cordless coil is a receive type surface coil.
When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a When wood in the nirrore to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin distinguision. Inc relaxation time (T1), and the spin-spin echo time (T2) of the corresponding nucleus.
When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.
(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device
Evaluation
Prescription Use_ V
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy bradon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050476
Traditional 510(k) Premarket Notification Cordless Coil for MAGNETOM Concerto and C! CONFIDENTIAL